US Food and Drug Administration approval of whole slide imaging for primary diagnosis: A key milestone is reached and new questions are raised

Andrew J. Evans, Thomas W. Bauer, Marilyn M. Bui, Toby C. Cornish, Helena Duncan, Eric F. Glassy, Jason Hipp, Robert S. McGee, Doug Murphy, Charles Myers, Dennis G. O'Neill, Anil V. Parwani, B. Alan Rampy, Mohamed E. Salama, Liron Pantanowitz

Research output: Contribution to journalReview article

28 Scopus citations

Abstract

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

Original languageEnglish (US)
Pages (from-to)1383-1387
Number of pages5
JournalArchives of Pathology and Laboratory Medicine
Volume142
Issue number11
DOIs
StatePublished - Nov 2018

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

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